BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONIC ACE

    MDR report key: 2999076 · Received February 25, 2013

    Report

    Report Number
    2999076
    Date Received
    February 25, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ETHICON ENDOSURGERY
    Product Code
    LFL
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    TIP BROKE OFF AGAINST METAL RETRACTOR. SALES REP TOOK PRODUCT TO RETURN TO COMPANY.MANUFACTURER RESPONSE FOR HARMONIC ACE, (BRAND NOT PROVIDED) (PER SITE REPORTER).TOOK DESCRIPTION OF INCIDENT & ISSUED A REPORT#. RETURN KIT WAS SHIPPED TO SALE REP.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RECTAL (TEMES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79218 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDOSURGERY * J92C14

    Patients

    Seq Age Sex Outcome Treatment
    1 *